The new Medical Devices Regulation (MDR) comes into force in May 2020 and represents a big shift in the regulatory framework governing medical devices. Software businesses could be particularly affected by the changes to regulation. Whilst many technology companies find their software is already considered to be a medical device under the regulations, the new guidelines could lead to changes in the classification for a large number of healthtech products.
The importance of complying with the guidelines cannot be overstated. Without the correct certification, software classified as a medical device under the regulations could be prohibited in both a post-Brexit UK and the EU market.
techUK are hosting a joint session with the MHRA to increase knowledge around software as a medical device and awareness of the forthcoming changes. Technology companies who may be affected are invited to attend to help them consider the requirements of the new legislation and understand the barriers to achieving compliance with MDR in time.
|
Introduction |
Ben Moody |
15.00-15.05 |
|
Software as a medical device and MDR 2020: What are the implications for tech industry? |
Graeme Tunbridge, MHRA |
15.05 – 15.25 |
|
Classification changes
|
David Grainger, MHRA |
15.25 – 15.45 |
|
Q+A |
Graeme Tunbridge, MHRA David Grainger, MHRA
|
15.45 – 16.00 |
|
Panel discussion: Industry response and comments on readiness for the changes? |
Bryn Sage, Intechnology Adrian Flowerday, Docobo Liz Ashall-Payne, Orcha Graeme Tunbridge, MHRA David Grainger, MHRA
|
16.00 – 16.30 |
-
View BioEllie Huckle
Programme Assistant | Public Sector
T 020 7331 2015
E This email address is being protected from spambots. You need JavaScript enabled to view it.
FROM SOCIAL MEDIA